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ObesityNCT01162668

Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

An observational study of Obesity, run by University of Mississippi Medical Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: to assess the health and economic outcomes (weight lost, change in control of chronic diseases such as diabetes, quality of life, work productivity, health care cost, etc) associated with bariatric (weight-loss) surgery for 200 severely obese patients who undergo bariatric surgery as part of the Mississippi… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
How many people
165 participants
Where
4 sitesUnited States
Study dates
Apr 2010to Jun 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 200 obese patients with Mississippi State Employee Insurance who undergo bariatric surgery as part of Obesity Treatment Program

Who may be able to join

  • Eligible bariatric surgical candidates who are enrolled in the Mississippi SSELHI Plan (100 candidates enrolled per year). The Plan's criteria includes, but is not limited to
  • enrollment in the plan for at least 12 consecutive months prior to September 1, 2009
  • completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program
  • a Body Mass Index (BMI) of >40 kg/m2, or a BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or asthma
  • two or more physician-supervised weight loss attempts within the last 24 months
  • consent to provide personal and medical information to the Plan

Who cannot join

  • Any patient who does not meet criteria above or who declines to participate.

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Central Mississippi Medical Center Comprehensive Weight Management Program

    Jackson, Mississippi, 39204

  • Oxford Bariatric

    Oxford, Mississippi, 28677

  • Oxford Surgical & Bariatric Clinic,LLC.

    Oxford, Mississippi, 38677

  • South Mississippi Surgical Weight Loss Center

    Pascagoula, Mississippi, 39567

Other trials in United States

About this study

Objective: to assess the health and economic outcomes (weight lost, change in control of chronic diseases such as diabetes, quality of life, work productivity, health care cost, etc) associated with bariatric (weight-loss) surgery for 200 severely obese patients who undergo bariatric surgery as part of the Mississippi State Employees' Life and Health Insurance Plan's Obesity Treatment Program (OTP).

  1. Patient Characteristics: Inclusion criteria: Eligible bariatric surgical candidates who are enrolled in the OTP (100 patients per year for 2 years). The Plan's criteria includes, but is not limited to 1) enrollment in the plan for at least 12 consecutive months prior to September 1, 2009; 2) completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program; 3) a Body Mass Index (BMI) of >40 kg/m2, or a BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or asthma; 4) two or more physician-supervised weight loss attempts within the last 24 months; 5) age 18 years or older; and 6) consent to provide personal and medical information to the Plan. Prior to surgery, each site administers a psychiatric evaluation to ensure the patient is psychologically stable for surgery. Exclusion criteria: any patient who does not meet criteria above or who declines to participate. Surgeries will take place only at Certified Bariatric Surgery Centers of Excellence (COE), of which, there are currently 3 in the state. The 3 COEs exist with 4 outpatient medical offices (1 COE is composed of 2 independent surgeon practices) Patients will be recruited at each site once they are approved by the OTP.
  2. Design: prospective, observational, multi-center, longitudinal study of outcomes and resource utilization associated with OTP. Estimates of obesity and comorbidities' impact will be obtained from the outpatient medical office for the COEs. Medical charts, databases and medical/pharmacy claims will be the source of information. Surveys on quality of life, productivity, and patient satisfaction will be administered directly to patients. Database claim information will be obtained in future and is not a part of current IRB application.

4: Procedures: After obtaining informed consent, patients will be administered surveys at baseline, as well as at follow-up visits. Additional data will be obtained via patient charts, databases, and medical/pharmacy claims.

Conditions
Obesity
Keywords
bariatric surgery, obesity, outcomes
Medical subject headings
Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

    change in weight from baseline

    Measured: 0, 6, 12, and 24 months

  2. Body mass index (BMI)

    Change in body mass index (BMI) from baseline

    Measured: 0, 6, 12, and 24 months

Secondary outcomes (6)
  1. ecomonic outcomes

    costs to the insurance plan were assessed

    Measured: 0, 6, 12, and 24 months

  2. Systolic blood pressure

    change in systolic blood pressure from baseline

    Measured: 0, 6, 12, and 24 months

  3. Diastolic blood pressure

    change in diastolic blood pressure from baseline

    Measured: 0, 6, 12, and 24 months

  4. Medication use

    Change in mean number of medications prescribed

    Measured: 0, 6, 12, and 24 months

  5. quality of life

    Impact of weight on quality of life (IWQOL-lite) questionnaire; tool assesses 5 domains of quality of life: physical function, self-esteem, sexual life, public distress, and work impact

    Measured: 0, 6, 12, and 24 months

  6. Work productivity

    Work productivity and activity impairment questionnaire: General Health v2.0 (WPAI:GH) assesses work productivity

    Measured: 0, 6, 12, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01162668
Sponsor's protocol ID
41165
Status last verified
May 2018
First submitted
13 Jul 2010
Last updated
15 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University of Mississippi Medical Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: 0, 6, 12, and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.

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